The following data is part of a premarket notification filed by Fujirebio Diagnostics, Inc. with the FDA for Lumipulse G He4 Immunoreaction Cartridges, Lumipulse G He4 Calibrators.
| Device ID | K151378 |
| 510k Number | K151378 |
| Device Name: | Lumipulse G HE4 Immunoreaction Cartridges, Lumipulse G HE4 Calibrators |
| Classification | Test, Epithelial Ovarian Tumor Associated Antigen (he4) |
| Applicant | Fujirebio Diagnostics, Inc. 201 Great Valley Parkway Malvern, PA 19355 |
| Contact | Diana Dickson |
| Correspondent | Stacey Dolan Fujirebio Diagnostics, Inc. 201 Great Valley Parkway Malvern, PA 19355 |
| Product Code | OIU |
| CFR Regulation Number | 866.6010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-05-22 |
| Decision Date | 2015-11-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04987270234181 | K151378 | 000 |
| 04987270234174 | K151378 | 000 |